If they were good enough for our presentation, why were these points not put in the "gold standard" clinical trials? You like that we will see these, so they must be good points right? Will the fda take i to account they are in our presentation? Can these items be looked at after the fact? Was is our management that decided to leave these out of the trial design? All of this couldn't be due to our experience could it?
And with regards to CLI, again I am not necessarily meaning off label. Just something in regards to all the changes that have and are taking place in the approval process. Through all the proper channels, they have a chance to make it through much easier with some good results in the CLI based measures.
And would the amputation rate be based on the DFU results. If they cure or help the ulcer, would that rate not go down? With no other treatment options, why wouldn't a physician look into other possible treatments, especially if the safety factor is taken out of the equation.
All I'm saying is these fast track and other designations, are not the best for companies like ours, who have spent years going through the proper process, only for some like Celularity to catch up in a much shorter timeframe. Do you not think the ex FDA commissioner on their board, along with many others, increases their chances of success? They use the same sourced cells.
Like I said before, going it alone with be the death sentence of this company imo. In the very least, decreases our chances substantially. Hopefully IC results will get us a big Pharma partner finally. I sure hope we get these in April. Time will tell.
